This invention relates to a packaging to hold a product during storage and transit under controlled environmental conditions, said packaging comprising a support member having a rigid portion supporting the product and a cover member sealed on the support member to maintain the controlled conditions, said cover member being applied on the product and against the support member for housing the product and for securing it to the support member.
Packagings of that kind are made for example to protect sterile medical appliances against the risk of becoming unsterile and contaminated and to maintain the shapes of the appliance during storage and transit. They are generally made to whenever possible facilitate the packaging procedure as well as the unpacking of the medical appliance.
In some known packagings of this kind, the cover member is a molded plastic blister, the pressed-out or outwardly projecting portion of which corresponds to the shapes of the relief of the packaged product located on the support member. Upon its enclosing into the packaging, the medical appliance must be precisely and carefully introduced into the molding of the blister before sealing thereof onto the support member, and there is therefore some risk to damage delicate portions of the medical appliance, such as for instance preshaped tips of stems of catheters. Upon extraction of the medical appliance from the packaging, the blister must be unsealed and separated from the support member up to the level of a portion of the medical appliance which can be grasped by the doctor, and the blister can be then completely separated from the support member so that the doctor may fully extract the medical appliance. This is a delicate job because due to the hollow shape of the blister molding there can be some creasing or cuts of the blister or even some retention in the blister which can damage the medical appliance at the place where it is still in the blister. Apart from this problem, that kind of packaging is by no means universally usable because any blister molding is specific to one shape and there is needed as many blister moldings as there may be different shapes for the medical appliance.
U.S. Pat. No. 5,105,942 describes a blister packaging which comprises, in the pressed-out portion corresponding to the delicate pre-shaped stem of the medical appliance, a corrugated profile the purpose of which is to create some flexibility in the blister to avoid the risk of having that package portion creasing or buckling or tearing. This improvement does not eliminate, however, the need to carefully introduce the medical appliance into the blister molding and the need to carefully extract it therefrom in order to avoid damaging its delicate portions. And it does also not bring any solution to the absence of universality of the blister molding concept, because for every individual catheter curvature a special blister sheet has to be molded. A further problem with this packaging is the unpacking. In order that the tip curvature does not get deteriorated due to overbanding, the catheter has to be unpacked laterally from the blister. This means that the seal between the blister and the support has to be opened all way along the full length of the catheter. However, after the support is removed from the blister the sterile catheter is relatively unprotected against contamination. This is the case during the opening procedure and between the opening procedure and the actual release of the catheter for use in a medical procedure. This problem is eliminated by the packaging disclosed in EP 0440427. In this configuration the shaped tip curvature of the catheter is secured in a blister molded insert which is lengthwise movable in a tray. The tray together with the insert and the catheter that it contains is taken up in a sterile pouch. For unpacking, the pouch is opened only on its narrow side and the catheter can then be taken out lengthwise. The specific design of the tray and the insert and the relative movement of the insert to the tray ensure proper lateral unpacking of the delicate tip of the catheter without stress for the tip curvature. During opening of the package and between opening and actual release for use the pouch is protecting like an envelope the full length of the catheter against unintentional unsterile contamination. For this function this packaging needs a tray, an insert and additionally the pouch. The insert has to be molded with corresponding individual tooling for every single tip shape configuration.
A further development, described in the document PACK AKTUELL, No. 2/93, provides for a packaging made of a twofold inflatable plastic bag forming two chambers within which a product may be placed. Upon inflation of the twofold bag, the two chambers enclose the product as sort of a clamping cushion. To handle the chambers or clamping cushion with the enclosed product during storage or transit, there is needed an outer packaging or box. Of course, upon removal of the outer box and deflation of the twofold bag, there is absolutely no environmental or mechanical protection of the product.